Metformin Plus Paclitaxel for Metastatic or Recurrent Head and Neck Cancer (METTAX)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Barretos Cancer Hospital
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Campinas, Brazil
Information provided by (Responsible Party):
Lucas Vieira dos Santos, Barretos Cancer Hospital
ClinicalTrials.gov Identifier:
NCT01333852
First received: April 5, 2011
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

Metformin plus paclitaxel for recurrent or metastatic head and neck cancer: a randomized phase II trial


Condition Intervention Phase
Head and Neck Neoplasms
Squamous Cell Carcinoma
Drug: metformin up to 2500mg/d
Drug: paclitaxel 175mg/m² q21d
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Phase II Study of Paclitaxel Plus Metformin or Placebo for the Treatment of Platinum-refractory, Recurrent or Metastatic Head and Neck Neoplasms

Resource links provided by NLM:


Further study details as provided by Barretos Cancer Hospital:

Primary Outcome Measures:
  • Disease control at week 12 [ Time Frame: 12th week ] [ Designated as safety issue: No ]
    Number of subjects at week 12 with complete response, partial response or stable disease, over the total number of subjects, for each arm. Disease control means complete response, partial response or stable disease, according to RECIST 1.1.


Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 6mo after the last patient recruited ] [ Designated as safety issue: No ]
    We will measure the number of subjects without progressive disease (complete response, partial response or stable disease) 6mo after the start of therapy, also after 1 and 2 years from the start of therapy. PFS will also be analysed with log-rank test, and reported as HR with respective 95% CI and p value, and median PFS will be estimated with kaplan-meyer method. All calculations will be performed 6 months after the last patient recruited. Also, the survival rate at year one and two will be calculated.

  • Overall Survival (subjects without death (any cause)) [ Time Frame: 6mo after the last enrolled patient ] [ Designated as safety issue: No ]
    We will measure the number of subjects without death (any cause) 6mo after the start of therapy, and also after 1 and 2 years from the start of therapy. OS will also be analysed with log-rank test, and reported as HR with respective 95% CI and p value, and median OS will be estimated with kaplan-meyer method. All calculations will be performed 6 months after the last patient recruited. Also, the survival rate at year one and two will be calculated.

  • Number of patients with Grade 3-5 Adverse Events in each arm, for each category of AE [ Time Frame: 6 mo after the last enrolled patients ] [ Designated as safety issue: Yes ]
    Safety and tolerability will be assessed using NCI CTCAE v3. The number of patients in each arm experiencing grade 3-5 AE (for each AE) over the total number of subjects will be measured, and the proportion of patients experiencing AE in each arm will be compared using uncorrected chi-sq test. AE will be recorded in baseline and in each visit, and the worst grade AE will be considered.


Estimated Enrollment: 45
Study Start Date: February 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Paclitaxel, placebo
Paclitaxel 175mg/m² q21d until disease progression, unacceptable toxicity or consent withdrawal
Drug: paclitaxel 175mg/m² q21d
paclitaxel 175mg/m² q21d
Other Name: taxol
Drug: placebo
placebo
Other Name: Placebo
Experimental: Paclitaxel plus metformin
Paclitaxel 175mg/m² q21d + metformin up to 2500mg/d until disease progression, prohibitive toxicity or consent withdrawal
Drug: metformin up to 2500mg/d
metformin up to 2500mg/d
Other Name: Glifage
Drug: paclitaxel 175mg/m² q21d
paclitaxel 175mg/m² q21d
Other Name: taxol

Detailed Description:

METTAX is a phase II randomized trial that aim to evaluate the addition of metformin to paclitaxel in patients that failed to curative-intent treatment for Head-and neck neoplasms.

Patients eligible for this protocol will be randomized to paclitaxel 175mg/m2 plus metformin or placebo until disease progression or unacceptable toxicity. The primary end-point is disease control (complete response, partial response or stable disease, according to RECIST 1.1) in the 12th week. Secondary end-points are PFS, OS, response rate and safety. Molecular markers in samples collected before and under treatment will be tested for correlation with clinical outcomes.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • Biopsy-proven head and neck squamous cell carcinoma
  • Ineligibility for curative intent therapy, e.g., surgery or radiation therapy
  • recurrent or stage IV disease
  • previous failure to platinum-based chemotherapy
  • measurable disease according to RECIST v1.1
  • PS ECOG 0-2

Exclusion Criteria:

  • known hypersensitivity to metformin or paclitaxel
  • SNC metastasis
  • Acute or chronic infection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01333852

Contacts
Contact: Lucas V dos Santos, M.D. +551733216600 ext 6829 lucasvsantos@yahoo.com
Contact: Andre L Carvalho, MD, PhD +551733216600 ext 7010 alopescarvalho@uol.com.br

Locations
Brazil
Barretos Cancer Hospital Recruiting
Barretos, SP, Brazil, 14784400
Contact: Lucas V. dos Santos, M.D.    +551733216600 ext 6788    lucasvsantos@yahoo.com   
Contact: Andre L Carvalho, MD, PhD    +551733216600 ext 7010    alopescarvalho@uol.com.br   
Principal Investigator: Lucas V. dos Santos, M.D.         
Sponsors and Collaborators
Lucas Vieira dos Santos
Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Campinas, Brazil
Investigators
Principal Investigator: Lucas V dos Santos, MD HCB
Study Chair: Jose BC Carvalheira, MD, PhD University of Campinas, Brazil
Study Director: Andre L. Carvalho, MD, PhD HCB
  More Information

No publications provided

Responsible Party: Lucas Vieira dos Santos, Dr, Barretos Cancer Hospital
ClinicalTrials.gov Identifier: NCT01333852     History of Changes
Other Study ID Numbers: METTAX200901
Study First Received: April 5, 2011
Last Updated: March 12, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Barretos Cancer Hospital:
head and neck cancer
paclitaxel
metformin
squamous cell carcinoma

Additional relevant MeSH terms:
Neoplasms
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
Paclitaxel
Metformin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 01, 2014